FDA will never give you a straight YES during initial discussions. That's what the approval process is for. It's a strong indication of what they think of the data at this time. And its not like they are dealing with it for the first rime. This is a very controversial issue, so for them to give the green light to submit with no clinical trial requirements, is as good as you'll get at this time in the process.
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-21
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